SmartMouth Advanced Clinical Formula Clinical Research Design Protocol (NCT02709785) | Clinical Trial Compass
CompletedNot Applicable
SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
United States80 participantsStarted 2016-03
Plain-language summary
The aim of this study is to provide evidence on the clinical efficacy of SmartMouth Advanced Clinical Formula mouthrinse in comparison to the efficacy of 0.12% chlorhexidine mouthrinse and a placebo mouthrinse. The placebo will be provided by the sponsor and will be identical to SmartMouth ACF (Advanced Clinical Formula), except it will not contain cetylpyridinium chloride, zinc chloride and sodium chlorite. The primary outcomes include measures of plaque and gingivitis. Secondary outcomes include evaluation of tooth discoloration, taste perception, malodor and calculus.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects between the ages of 18 to 80
* Subjects with a diagnosis of gingivitis or chronic periodontitis
* Entry levels of gingival inflammation and plaque accumulation will be present (mean Gingival Index ≥ 0.4 and Plaque Index ≥ 1.0)
* Subjects that are in good medical health at time of the study
* At least 20 permanent natural teeth
Exclusion Criteria:
* Use of local or systemic antibiotics during the course of the study
* Subjects that are pregnant or nursing mothers
* Subjects undergoing orthodontic therapy
* Subjects wearing removable prostheses
* Subjects taking medication which is altering the gingiva or causing inflammation
* Gingival overgrowth
* History of sensitivity or suspected allergies following the use of oral hygiene products
* Subjects taking anti-inflammatory or anticoagulant medications that would alter the gingiva and promote bleeding
* Subjects that require antibiotic prophylaxis prior to dental treatment
* Subjects that have acute dental problems requiring immediate treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.